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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

ABSTRACT: Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed.This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial.This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams.ClinicalTrials.gov NCT00567333.

SUBMITTER: Westrom KK

PROVIDER: S-EPMC2841162 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

Westrom Kristine K KK Maiers Michele J MJ Evans Roni L RL Bronfort Gert G

Trials 20100308

<h4>Background</h4>Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for ch ...[more]

PMID: 20210996

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Project description:BACKGROUND: There is considerable clinician and researcher interest in whether the outcomes for patients with low back pain, and the efficiency of the health systems that treat them, can be improved by 'subgrouping research'. Subgrouping research seeks to identify subgroups of people who have clinically important distinctions in their treatment needs or prognoses. Due to a proliferation of research methods and variability in how subgrouping results are interpreted, it is timely to open discussion regarding a conceptual framework for the research designs and statistical methods available for subgrouping studies (a method framework). The aims of this debate article are: (1) to present a method framework to inform the design and evaluation of subgrouping research in low back pain, (2) to describe method options when investigating prognostic effects or subgroup treatment effects, and (3) to discuss the strengths and limitations of research methods suitable for the hypothesis-setting phase of subgroup studies. DISCUSSION: The proposed method framework proposes six phases for studies of subgroups: studies of assessment methods, hypothesis-setting studies, hypothesis-testing studies, narrow validation studies, broad validation studies, and impact analysis studies. This framework extends and relabels a classification system previously proposed by McGinn et al (2000) as suitable for studies of clinical prediction rules. This extended classification, and its descriptive terms, explicitly anchor research findings to the type of evidence each provides. The inclusive nature of the framework invites appropriate consideration of the results of diverse research designs. Method pathways are described for studies designed to test and quantify prognostic effects or subgroup treatment effects, and examples are discussed. The proposed method framework is presented as a roadmap for conversation amongst researchers and clinicians who plan, stage and perform subgrouping research. SUMMARY: This article proposes a research method framework for studies of subgroups in low back pain. Research designs and statistical methods appropriate for sequential phases in this research are discussed, with an emphasis on those suitable for hypothesis-setting studies of subgroups of people seeking care.

Project description:BACKGROUND:At any one time, one in every five Canadians has low back pain (LBP), and LBP is one of the most common health problems in primary care. Guidelines recommend that imaging not be routinely performed in patients presenting with LBP without signs or symptoms indicating a potential pathological cause. Yet imaging rates remain high for many patients who present without such indications. Inappropriate imaging can lead to inappropriate treatments, results in worse health outcomes and causes harm from unnecessary radiation. There is a need to understand the extent of, and factors contributing to, inappropriate imaging for LBP, and to develop effective strategies that target modifiable barriers and facilitators. The primary study objectives are to determine: 1) The rate of, and factors associated with, inappropriate lumbar spine imaging (x-ray, CT scan and MRI) for people with non-specific LBP presenting to primary care clinicians in Ontario; 2) The barriers and facilitators to reduce inappropriate imaging for LBP in primary care settings. METHODS:The project will comprise an inception cohort study and a concurrent qualitative study. For the cohort study, we will recruit 175 primary care clinicians (50 each from physiotherapy and chiropractic; 75 from family medicine), and 3750 patients with a new episode of LBP who present to these clinicians. Clinicians will collect data in the clinic, and each participant will be tracked for 12?months using Ontario health administrative and self-reported data to measure diagnostic imaging use and other health outcomes. We will assess characteristics of the clinicians, patients and encounters to identify variables associated with inappropriate imaging. In the qualitative study we will conduct in-depth interviews with primary care clinicians and patients. DISCUSSION:This will be the first Canadian study to accurately document the extent of the overuse of imaging for LBP, and the first worldwide to include data from the main healthcare professions offering primary care for people with LBP. This study will provide robust information about rates of inappropriate imaging for LBP, along with factors associated with, and an understanding of, potential reasons for inappropriate imaging.

Project description:Low back pain is the highest reported musculoskeletal problem worldwide. Up to 90 % of patients with low back pain have no clear explanation for the source and origin of their pain. These individuals commonly receive a diagnosis of non-specific low back pain. Patient education is a way to provide information and advice aimed at changing patients' cognition and knowledge about their chronic state through the reduction of fear of anticipatory outcomes and the resumption of normal activities. Information technology and the expedited communication processes associated with this technology can be used to deliver health care information to patients. Hence, this technology and its ability to deliver life-changing information has grown as a powerful and alternative health promotion tool. Several studies have demonstrated that websites can change and improve chronic patients' knowledge and have a positive impact on patients' attitudes and behaviors. The aim of this project is to identify chronic low back pain patients' beliefs about the origin and meaning of pain to develop a web-based educational tool using different educational formats and gamification techniques.This study has a mixed-method sequential exploratory design. The participants are chronic low back pain patients between 18-65 years of age who are attending a primary care setting. For the qualitative phase, subjects will be contacted by their family physician and invited to participate in a personal semi-structured interview. The quantitative phase will be a randomized controlled trial. Subjects will be randomly allocated using a simple random sample technique. The intervention group will be provided access to the web site where they will find information related to their chronic low back pain. This information will be provided in different formats. All of this material will be based on the information obtained in the qualitative phase. The control group will follow conventional treatment provided by their family physician.The main outcome of this project is to identify chronic low back pain patients' beliefs about the origin and meaning of pain to develop a web-based educational tool using different educational formats and gamification techniques.ClinicalTrials.gov NCT02369120 Date: 02/20/2015.

Project description:BackgroundSelf-management is the key recommendation for managing nonspecific low back pain (LBP). However, there are well-documented barriers to self-management; therefore, methods of facilitating adherence are required. Smartphone apps are increasingly being used to support self-management of long-term conditions such as LBP.ObjectiveThe aim of this study was to assess the usability and acceptability of the SELFBACK smartphone app, designed to support and facilitate self-management of non-specific LBP. The app provides weekly self-management plans, comprising physical activity, strength and flexibility exercises, and patient education. The plans are tailored to the patient's characteristics and symptom progress by using case-based reasoning methodology.MethodsThe study was carried out in 2 stages using a mixed-methods approach. All participants undertook surveys, and semistructured telephone interviews were conducted with a subgroup of participants. Stage 1 assessed an app version with only the physical activity component and a web questionnaire that collects information necessary for tailoring the self-management plans. The physical activity component included monitoring of steps recorded by a wristband, goal setting, and a scheme for sending personalized, timely, and motivational notifications to the user's smartphone. Findings from Stage 1 were used to refine the app and inform further development. Stage 2 investigated an app version that incorporated 3 self-management components (physical activity, exercises, and education). A total of 16 participants (age range 23-71 years) with ongoing or chronic nonspecific LBP were included in Stage 1, and 11 participants (age range 32-56 years) were included in Stage 2.ResultsIn Stage 1, 15 of 16 participants reported that the baseline questionnaire was easy to answer, and 84% (13/16) found the completion time to be acceptable. Overall, participants were positive about the usability of the physical activity component but only 31% (5/16) found the app functions to be well integrated. Of the participants, 90% (14/16) were satisfied with the notifications, and they were perceived as being personalized (12/16, 80%). In Stage 2, all participants reported that the web questionnaire was easy to answer and the completion time acceptable. The physical activity and exercise components were rated useful by 80% (8/10), while 60% (6/10) rated the educational component useful. Overall, participants were satisfied with the usability of the app; however, only 50% (5/10) found the functions to be well integrated, and 20% (2/10) found them to be inconsistent. Overall, 80% (8/10) of participants reported it to be useful for self-management. The interviews largely reinforced the survey findings in both stages.ConclusionsThis study has demonstrated that participants considered the SELFBACK app to be acceptable and usable and that they thought it would be useful for supporting self-management of LBP. However, we identified some limitations and suggestions useful to guide further development of the SELFBACK app and other mobile health interventions.

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

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Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

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